Events

Alerta De Seguridad para Infusion pump CADD

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Smiths Medical Asd, Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1605-216
  • Número del evento
    2015EBC-0013709
  • Fecha
    2016-05-24
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=139
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has detected that when using the referenced medical devices, a lower infusion rate than the programmed one can be presented, resulting in insufficient therapy, which could lead to the potential occurrence of adverse events on the patients.

Device

Infusion pump CADD
  • Modelo / Serial
    Administration Set references 21-7321-24, 21-7322-24, 21-7323-24, 21-7324-24, 21-7333-24, || 21-7336-24, 21-7339-24, 21-7359-24, 21-7383-24, 21-7390- || 24, 21-7391-24, 21-7394-24 and 21-7395-24, dated || expiration equal to or before March 2021.
  • Descripción del producto
    The CADD SOLIS ambulatory infusion pump system provides a pharmacotherapy measured in patients in hospital and outpatient areas. The ambulatory infusion pump CADD SOLIS is indicated for intravenous infusion, intra-arterial, subcutaneous, intraperitoneal, near the nerves, in an intraoperative site (soft tissues, site of the body cavity / surgical wound) and the epidural or subarachnoid spaces. The pump is designed for techniques that require a continuous rate of infusion and / or intermittent unbolo and / or on demand doses controlled by the patient.
  • Manufacturer
    Smiths Medical Asd, Inc.

Manufacturer

Smiths Medical Asd, Inc.